Date Initiated by Firm |
November 01, 2013 |
Date Posted |
November 19, 2013 |
Recall Status1 |
Terminated 3 on December 17, 2013 |
Recall Number |
Z-0360-2014 |
Recall Event ID |
66720 |
510(K)Number |
K894350
|
Product Classification |
Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
|
Product |
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203.
CO2 sample line.
|
Code Information |
Model number: 4515-15-25; lot numbers 071513, 071513A and 120312. |
Recalling Firm/ Manufacturer |
SALTER LABS 100 Sycamore Rd Arvin CA 93203-2300
|
For Additional Information Contact |
Colleen Moyne 760-795-7089
|
Manufacturer Reason for Recall |
It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
|
FDA Determined Cause 2 |
Labeling Change Control |
Action |
Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received.
All customers letters were sent certified mail, return receipt requested. |
Quantity in Commerce |
91 cases (25 units per case) |
Distribution |
Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CCK and Original Applicant = SALTER LABS
|